POLISH INFORMATION AND FOREIGN INVESTMENT AGENCY

PHARMACEUTICAL
AND BIOTECHNOLOGICAL
SECTOR IN POLAND
© Foto: Alexander Raths – Fotolia.com
Pharmaceutical sector worldwide, further growth prospects
The current value of the global pharmaceutical industry is ca. USD 1,000 bn (it is expected to be growing
less than 10 per cent in the nearest future). The United States (28 per cent of worldwide sales), the Euro-
pean Union (15 per cent) and Japan (12 per cent) are the key global markets for pharmaceutical industry.
These three markets make ca. 55 per cent of pharmaceutical product sales volume worldwide. However,
they may be gradually losing their significance in the years to come with the tendency of the governments in
Western countries to cut down healthcare expenditures, including drug reimbursements. In the nearest future,
emerging economies (the so-called pharmerging markets) will be the key driving force for the sector as their
governments will be considerably increasing healthcare expenditures. Among these economies, China will be
the biggest player. It is already an important market, the significance of which will grow rapidly in the future.
The projections that are being made include society-aging-related (particularly in Europe) generic drug
market growth and using biotechnology as drug manufacturing tool as two most important trends for sector
growth. In 2012, up to 7 out of 10 global blockbuster drugs will be biotechnological medicines.1

Description of the pharmaceutical sector in Poland

The past twenty years have seen a number of fundamental changes in the Polish pharmaceutical market,
which is one of the oldest industries in our country. Ownership structure of companies has changed with
state-owned companies turning into private entities. New regulations such as amended drug sales rules
have been implemented. In terms of administration, public healthcare management system has changed
(Healthcare Funds were established and then replaced with the National Health Fund (NHF). The sector
structure has also changed: we have observed a gradual increase in the number of retail and wholesale
pharmacies and subsequent consolidation thereof and the increasing significance of foreign investors oper-
ating in the pharmaceutical industry.2

Diagram 1. Polish pharmaceutical market value and dynamics

25 20%
22.3
18%
20.1
19.4
20 16%
17.6
16.1 14%
14.8 12.0%
14.2
15 12.9 13.2 10.9% 12%

PLN bln
9.3% 10%
7.6% 8.0%
10 8%

6%
4.2%
3.6%
5 4%
2.3%
2%

0 0%
2003 2004 2005 2006 2007 2008 2009 2010 2011

Dynamics Pharmaceutical market value

Source: Wkład innowacyjnego przemysłu farmaceutycznego w rozwój polskiej gospodarki, Raport, PwC, Polish Pharmaceutical
Sector Report October 2012, Intellinews 2012 [Contribution of the Innovative Pharmaceutical Industry in the Development of
Polish Economy, Report, PwC, Polish Pharmaceutical Sector Report October 2012, Intellinews 2012].

In the last 10 years the pharmaceutical market in Poland has seen continuous growth, reaching PLN 22.3
bn in 2011. The sales noted impressive increase – by 11% in the comparison to the previous year. In 2010,
pharmaceutical industry generated 0.8 per cent of the Polish GDP. Currently Poland is ranked as the big-
gest medical market in Central Europe (sixth biggest in Europe) with bright outlook for the coming years.
Healthcare expenditures amount to 7.4 per cent of the Polish GDP, which surpasses the average expendi-
tures in the region but is lower than in Western Europe (10%). As much as 68 per cent of the expenditures
are covered by the National Health Fund, while families cover 24 per cent. According to the forecast, by
2016 healthcare expenditures in Poland will have increased by ca. 50 per cent to reach PLN 150 bn, and
the share of the state in this amount is due to increase3.
Medical market is divided into 2 segments: pharmacies and hospitals. In 2010 86% of medicines in Po-
land were sold in pharmacies, with prescription drugs (reimbursed or not) making 67% of market value and
other drugs sold in pharmacies making 19%. Drugs destined for the hospitals made the remaining 14% of
the market value.

1
  „Biotechnologia to specjaliści i nowoczesne zaplecze”, Puls biznesu, 9 września 2012. [“Biotechnology – Specialists and
State-of-the-Art Facilities” , Puls biznesu, 9 September 2012].
2
  “Jak zmieniał się rynek farmaceutyczny w Polsce.” Aptekarz Polski, wrzesień 2011, nr 61/39 online. [The Way the Polish
Pharmaceutical Market Has Changed.”, Aptekarz Polski, September 2011, no. 61/39 online.
3
  A World Pharmaceutical Market Report, Espicom Business Intelligence 2012, pages 13–14.

1
 19.2%

19.2%
50.5%
Diagram 2. Polish pharmaceutical market structure in 2010 Table 1. The largest pharmaceutical companies in Poland
50.5%
13.9%
Pharmaceutical
Largest pharmaceutical companies operating in Poland in 2010 (by value)
market share
16.5%
Sanofi-Grupa (including Zentiva) Rzeszów, Chociw 8.5%
Prescription drugs, reimbursed Prescription drugs, not reimbursed
19.2% 16.5% Novartis (including Sandoz) Stryków 8.2%
Non-prescription drugs Hospital drugs
Prescription drugs, reimbursed Prescription drugs, not reimbursed GSK Poznań 6.1%
Non-prescription drugs 50.5% Hospital drugs Polpharma Starogard Gdański, Duchnice, Sieradz 5.2%
Roche Warszawa 4.6%
Servier Warszawa 3.9%
16.5%
Merck (MSD) Warszawa 3.8%
Source: Raport na tematdrugs,
Prescription ustawy o refundacji lekówPrescription
reimbursed implementacja oraz
drugs, not wpływ na uczestników rynku, IMS 2011. [Drug Reimbur-
reimbursed
Pfizer Warszawa 3.4%
sement Act – Non-prescription
Implementation and Impact on Market
drugs Participants,
Hospital drugs Report, IMS 2011].
Teva Group Kraków, Kutno 3.1%
75 per cent of the prescription drugs were refunded by the National Health Fund which spent PLN 8.5 bn on reim- AstraZeneca Warszawa 3.1%
bursement in 2010. According to the forecasts, drug reimbursement expenditures will be falling gradually due KRKA Warszawa 3.0%
to a reimbursement ceiling recently set by the Polish government (the so-called Drug Reimbursements Act). Adamed (including Polfa Pabianice) Pieńków, Pabianice 2.8%
At the same time, Polish pharmaceutical market is dominated by imported medicines. The present share Source: Wkład innowacyjnego przemysłu farmaceutycznego w rozwój polskiej gospodarki, PwC, 2011 [The Contribution of the
of value of drugs manufactured in Poland in the total prescription drug sales volume is ca. 24 per cent. Innovative Pharmaceutical Industry in the Development of Polish Economy, PwC, 2011].
In 2010, this share amounted to PLN 3.9 billion against the total sales volume amounting to PLN 16.3 bn.4
In 2011 the imports volume amounted to EUR 3,66 bn and exports to PLN 1.49 bn. It should also be noted
that despite the strong negative balance of trade, the exports in last eight years grew annually by 29 per According to BMI, Poland is becoming more and more attractive investment location for R&D and
cent while imports only by 8.8 per cent. The major receivers of Polish drugs are: Germany (16.8%), Russia clinical trials, thanks to a large population of patients and relatively low operational costs. In 2010 the value
(10.5%) and Italy (9.4%) while major drugs’ suppliers are Germany (17.6 per cent), France (17 per cent) of the said market was ca. PLN 900 million, which made it the largest such market in Central and Eastern
and Great Britain (12.3 per cent). 5 Europe, and in the coming years it is expected to grow by 5 per cent annually according to the forecasts by
the analytical company PMR. From 17,000 new trials registered worldwide in 2009, 469 trials, (2.5 per cent)
The Polish pharmaceutical market is dominated by generic drugs with share amounting to 66 per cent were registered in Poland. Our country is ranked 10th worldwide in terms of the number of centres carrying out
(the biggest share in terms of products sold in Europe)6. As a result, medicines in Poland are among the clinical trials and 1st among the so-called emerging markets (1.176 centres, 1.6 per cent of all centres carrying
cheapest in Europe (44 per cent of average price in Europe). Access to innovative drugs in Poland is rather out clinical trials worldwide). There are about 50 centres in Poland, which accept contracts for performance
limited, which is largely due to the patients’ high share in financing the purchase of such drugs, which is of clinical trials. Some companies such as AstraZeneca have decided to open their own clinical trial centres.
connected with limited financing by the National Health Fund 7. Most clinical trials are carried out in oncology and cardiology, but also diabetology and pulmonology.8

Diagram 3. Share of generic drug sales volume in 2010 by value (pharmacy market, %)
Labour market potential in Poland
In the first half of 2012 there were over 21,000 employees in pharmaceutical production sector, which
amounted to ca. 0.26 per cent of the total number of employees in Poland. Every third employee was em-
ployed in a small or medium-sized company. The estimated total employment rate in the pharmaceutical
sector is 31.000 employees with 11.000 of them employed in innovative companies. Retail and wholesale
pharmacies offer another 80.000–90.000 workplaces.9 There are about 4.000 employees in the biotechno-
logical sector.
Labour market potential is determined by a large number of students of pharmacy and biotechnology.
In 2009/2010 there were more than 8.000 students of pharmacy. Nearly 13.000 students chose to study
biotechnology. Pharmacy as a field of study is offered by 12 medical universities in Poland. 39 higher
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biotechnology as a field of study (30 institutions offered PhD studies).10 In 2009/2010 there were over 4.100
m
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ze

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G

Source: Raport na temat ustawy o refundacji leków implementacja oraz wpływ na uczestników rynku, IMS 2011. [Drug Reimbur-
sements Act – Implementation and Impact on Market Participants, Report, IMS 2011].
The most distinct trend in the international pharmaceutical industry is an increase in innovative therapies
based on biotechnological products. One of the most innovative biotechnological medicine currently pro-
duced in Poland is recombinant human insulin, manufactured by Bioton. Besides that, implementation of
new manufacturing technologies for biosimilar medicines is currently underway. Product develop-
ment is currently the strategic focus area for biotech and pharmaceutical companies.
The Polish pharmaceutical market is mature, with 450 enterprises operating there at present. The phar-
maceutical sector in Poland is virtually in private hands (mostly foreign investors). Additionally, about 70
enterprises in Poland operate in the biotechnological sector.
4
  Wkład innowacyjnego przemysłu farmaceutycznego w rozwój polskiej gospodarki, Raport, PwC 2011, s. 22. [The Contribution
of Innovative Pharmaceutical Industry in the Development of Polish Economy, PwC, 2011, page 22].
5 9
  A World Pharmaceutical Market Report, Espicom Business Intelligence 2012, pages 32–38.
6
  Raport na temat ustawy o refundacji leków. Implementacja oraz wpływ na uczestników rynku, IMS 2011, s. 18. [Drug
Reimbursements Act. Implementation and Impact on Market Participants, Report, IMS 2011, page 18].
7 11
  Wkład innowacyjnego przemysłu farmaceutycznego w rozwój polskiej gospodarki, 2011, PwC. [The Contribution of Innovative
Pharmaceutical Industry in the Development of Polish Economy, PwC, 2011].
biotechnology and pharmacy graduates. The greatest numbers of pharmacy students were reported in
Śląskie (12.3 per cent of the total number of pharmacy students) and Lubelskie and Małopolskie Provinces
(11.3 per cent in each province). In case of biotechnology (available in 15 provinces), the biggest numbers
of students were reported in Śląskie, Dolnośląskie and Łódzkie Provinces (14.3 per cent, 14.0 per cent and
11.9 per cent respectively).11 Except for studies in the Polish language, higher education institutions also
introduced biotechnology studies in the English language. Furthermore, 208 colleges in Poland edu-
cate pharmaceutical technicians.12
It is estimated that currently there are too many graduates, and this applies particularly to biotechnol-
ogy as the market growth in Poland is slow. Nonetheless, as regards the latter profile, for many years the
number of applicants has been invariably four times bigger than that of the available places.
8
  Go Global! Polish Pharma. Raport o innowacyjności polskiego sektora farmaceutyczno-medycznego, Grupa Inicjatywna Go
Global! Polish Pharma, 2012, s. 54–56, “Producenci leków stawiają na Polskę”, “Dziennik Gazeta Prawna, 21 października
2011 r. [Go Global! Polish Pharma. Report on innovation in the Polish medical and pharmaceutical sector, Go Global Initiative
Group! Polish Pharma, 2012, pages 54–56, “Drug Manufacturers Bet on Poland”, “Dziennik Gazeta Prawna”, 21 October 2011]
  Wkład innowacyjnego przemysłu farmaceutycznego w rozwój polskiej gospodarki, Raport, PwC 2011, s.7 [The Contribution of
Innovative Pharmaceutical Industry in the Development of Polish Economy, PwC, 2011, page 7].
10
  Pharmaceutical biotechnology in Poland: current conditions and forecasts, PMR 2011.
  GUS 2011.
12
  Educational Information System 2012.

2 3
 In the said period the average gross monthly salary in the pharmaceutical sector was PLN 5373.13 (ca.
EUR 1280) and surpassed the average salary in Poland (PLN 3496.82) by nearly 55 per cent13. None-
theless, in both pharmacy and biotechnology the salaries (average salary of young specialist in biotechnol-
ogy amounts to PLN 2000–2500).14 are still much lower than in Western Europe.
Investments and market potential
Figure 1. The largest foreign investments in the pharmaceutical sector in Poland
* IT centre
Source: Own materials
Foreign investors have the biggest share in the Polish pharmaceutical market. For the last 20 years they
have been opening new sites and taking part in privatisation of existing companies. Germany, France and
Great Britain are the main countries investing in the pharmaceutical sector in Poland.
The largest enterprises in the Polish market are foreign corporations: Sanofi (France), Novartis (Switzer-
land) and GSK (UK).
It is also worth noting that business expenditures for B+R projects in Poland increased last year over 800%
(from PLN 258 mln to PLN 2.12 bn). Also, public expenses in this field noted a significant increase – Ministry
of Science and Higher Education funds together with National Centre of Science and National Centre of
Research and Development grants amounted to PLN 1.28 bn.
Foreign investors perceive Poland as a country with high-level knowledge and research potential. A fo-
cus of Polish pharmaceutical industry on the manufacture of generic medicines creates possibilities for
investing in the development of innovative medicines in the pre-clinical phase, which involves relatively
lower costs. Manufacturers of traditional medicines (e.g. Adamed Group and Celon Pharma Sp. z o.o.) and
companies working across the biotech and pharmaceutical industry (e.g. Selvita S.A., Blirt S.A., Celther
Polska Sp. z o.o., Stem Cells Spin S.A. and Proteon Pharmaceuticals S.A.) are increasingly focused on the
development of new innovative medicines.15 Poland offers also good conditions for the development and
manufacture of biosimilar medicines which are likely to be the future of the pharmaceutical industry.16
Another growth opportunity for the industry is the development of personalised therapies.
Poland has one of the lowest annual per capita drug expenditures in Europe amounting to EUR 114 which
represents 52% of the European average. Drug prices in Poland are also among the cheapest in Europe
(44% of the European average). Consequently, according to research companies, Poland remains a long-
term market leader in the pharmaceutical industry and the most attractive market in the CEE.17 One
of the reasons is that Poland has relatively large and aging population which places the country among the
top 14 largest global pharmaceutical markets, 6 largest markets in Europe and second largest in the CEE
(after Russia). Other important factors include the increasing acceptance of self-medication and the growing
number of patients with diabetes and hypertension.18 It is estimated that despite the market turmoil in 2012
due to the introduction of new reimbursement regulations, the pharmaceutical market is set for a dynamic
growth. However, expert forecasts vary considerably as to the expected rate of growth. According to Espi-
com, Polish pharmaceutical market will grow 9.2 annually in PLN (and about 10% in USD) between 2011 and
2016 whereas Datamonitor is forecasting an average annual growth rate of 4.9% between 2010 and 2015.
13
  Central Statistical Office (GUS) 2012.
14
  Own materials
15
  Report On Polish Biotech and Pharma, Biotech Consulting 2012 page 3
16
  Go Global! Polish Pharma. Raport o innowacyjności polskiego sektora farmaceutyczno-medycznego, Grupa Inicjatywna
Go Global! Polish Pharma, 2012, s. 60–65. [Go Global! Polish Pharma. Report on innovation in the Polish medical and
pharmaceutical sector, Go Global Initiative Group! Polish Pharma, 2012, page 60–65]
17
  Business Monitor International 2012
18
  Business Monitor International 2012
4 5
Polish pharmaceutical sector has extensive know-how in the manufacture and improvement of generic
products which account for 85% of the total market turnover by quantity and 66% by value.19 According to
Business Monitor International (BMI), the market share of generic products in Poland will fall within the next
10 years to about 50% of the total turnover. At the same time, the market is expected to grow from PLN
14.4 bn to PLN 18.5 bn in 2016, i.e. at an annual rate of 5.2 (8.7% in USD) due to domestic demand and
budgetary savings in other countries.
Poland is an attractive investment location for biotech and pharmaceutical companies mainly due to high-
skilled workforce, low labor costs (compared to the Western Europe), manufacturing cost effectiveness,
significant know-how in the manufacture and improvement of generic products as well as high potential
and growing experience in clinical research projects. Foreign investors also recognise other advantages of
the market which include regulatory compliance (particularly with respect to managing intellectual property
rights and compliance with quality procedures) and transparent terms of cooperation.20 It should also be
noted that the pharmaceutical sector receives state support – R&D projects are co-financed by EU and
state funds while biotechnology is included by the Minister of Science and Higher Education in the list of
priority study programmes. Currently, the main problem facing companies operating in the Polish pharma-
ceutical sector are legal and administrative procedures. Still, this situation has been gradually improving
thanks to government policy and EU integration requirements.
As a manufacturer of mainly generic products and, at the same time, a country with a growing readiness
for consolidation, Poland is an attractive market for acquisitions and mergers, especially those aimed at
obtaining a competitive advantage in the years 2012‑2014, as over 100 patents on generic drugs
are due to expire in this period. Consolidation activities21 in the pharmaceutical market are also
expected to take place in the following years – both in the area of manufacturing and distribution.
A significant increase in the number of such transactions has already been observed.22
Technology parks, clusters and industry groups
According to PwC, each pharmaceutical company takes part in at least 5 projects aimed at building an
industry coalition.23 Therefore, the pharmaceutical industry includes a number of clusters and technologi-
cal parks providing an infrastructure for development of innovative biotech and pharmaceutical products,
particularly laboratory facilities.24
Figure 2. Pharmaceutical and Biotechnology clusters and Science and Technology Parks in Poland
Gdansk Science & Technology Park
Pomeranian Science and Technology Park
Poznan Science & Technology Park
Nickel Technology Park Poznan
Polish Technology Platform for Innovative Medicine
Ochota Biocentre Consortium
InnoBioBiz Cluster Lódz
The BioTechMed Advanced Technology Centre
Technopark Lódz
Nutribiomed Cluster
The Wroclaw Research Centre EIT+
Wroclaw Technology Park
LifeScience Cluster Kraków
Technology Park at the Jagiellonian Centre of Innovation
The Wroclaw Research Centre EIT+
Source: PAIiIZ
The list of clusters is provided below:25
1. Nutribiomed Cluster
The cluster was established in 2007. It has 40 members, including: 6 higher education institutions (e.g.
Wrocław University of Environmental and Life Sciences, University of Wrocław, Wrocław Medical University
19
  Go Global! Polish Pharma. Raport o innowacyjności polskiego sektora farmaceutyczno-medycznego, Grupa Inicjatywna Go
Global! Polish Pharma, 2012, s. 55. [Go Global! Polish Pharma. Raport o innowacyjności polskiego sektora farmaceutyczno-
medycznego, Grupa Inicjatywna Go Global! Polish Pharma, 2012, page 55]
20
  Ibidem, 2012, page 62
21
  Business Monitor International 2012
22
  Polish Pharmaceutical Sector Report, Intellinews 2012, page 11 and following pages
23
  Wkład innowacyjnego przemysłu farmaceutycznego w rozwój polskiej gospodarki, PwC 2011. [Contribution of the Innovative
Pharmaceutical Industry to the Development of Polish Economy, PwC, 2011]
24
  Report On Polish Biotech and Pharma, Biotech Consulting 2012 pages 10–12
25
  Ibidem pages 5–7 and information obtained from various institutions.
 and Poznań University of Life Sciences), 3 business support institutions (including Wrocław Technology
Park) and 31 companies.
The main idea behind the cluster is to combine innovative knowledge-based economy with development of
biomedical technology to manufacture food supplements, nutraceuticals and products for pharma-
ceutical use. Activities of the cluster are also aimed at improving food preservation technologies and creating
modern bioplastic packages. The cluster covers the area of Lower Silesia, southwest and central Poland.
2. LifeScience Cluster Kraków
Established in 2006 on the initiative of the Jagiellonian University, LifeScience Cluster Kraków com-
prises several dozen institutions, including 21 enterprises, 15 health institutions, 5 science and research
institutes (including the Institute of Pharmacology of the Polish Academy of Sciences), 6 higher education
institutions, 19 business environment institutions and 3 institutions representing local and state authorities
in the region. The objectives of the cluster include supporting entrepreneurship and innovation in the
area of life science and creating conditions for successful commercialization of research.
3. Polish Technology Platform for Innovative Medicine (PTPIM)
PTPIM was created in 2003. It comprises 20 entities, mainly enterprises engaged in conducting and financ-
ing research projects on new medicines, medical technologies, modernisation of medical equipment
and innovations for the medical market. The main goal of the cluster is to support development of in-
novative pharmaceutical solutions and improve competitiveness of the pharmaceutical sector in Poland.
4. The BioTechMed Advanced Technology Centre
BioTechMed Centre is a consortium of entities, mainly R&D and business environment institutions, in-
cluding the Centre of Molecular and Macromolecular Studies and the Institute for Medical Biology of the
Polish Academy of Sciences. The Centre holds 14 patents and 4 patent applications. It is committed
to conducting joint long-term R%D and research and implementation projects for developing new
technologies and services in areas related to protection and improvement of human health and environ-
mental protection using advances in biotechnology, technology and medical sciences. Research projects
conducted within the consortium cover areas of medical biology, chemical biology, medical chemistry,
virology as well as life and pharmaceutical sciences.
5. Ochota Biocentre Consortium of the Polish Academy of Sciences
The Consortium was founded in 2008 on the initiative of 6 research institutes of the Polish Academy of Sci-
ences operating in the Ochota Campus in Warsaw. The founders include: Institute of Biochemistry and Bio-
physics, Institute of Biocybernetics and Biomedical Engineering, Nencki Institute of Experimental Biology,
Mossakowski Medical Research Centre, Institute of Fundamental Technological Research and International
Institute of Molecular and Cell Biology. Ochota Biocentre Consortium is mainly committed to combining
the research potential for conducting large-scale research projects beyond the capability of individual
members. Such projects cover the areas of biology, medicine and bioengineering.
6. InnoBioBiz Cluster Łódź
InnoBioBiz Cluster was established in 2011 by Łódź-based biotech companies and business environment
institutions. It also comprises the Medical University of Łódź and the University of Łódź. The cluster is com-
mitted to creating conditions for development and promotion of innovative business in the region based on
the potential of biotech companies.
Contact details of all technological parks, clusters, consortiums and other industry groups are available in
section “Contact details of main institutions”.
Investment incentives
Enterprises implementing new investments in Poland may apply for various forms of support as part of the
so called regional aid, including non-repayable grants (state or co‑financed by the EU) and tax exemptions
(CIT exemption in Special Economic Zones and local tax exemptions).
Investors planning investments in strategic sectors (including biotechnology sector) may apply for two types
of grants: financial support for creation of new jobs and/or support for new investment as part of the “Pro-
gram for supporting investment of strategic importance for Polish economy 2011–2020”. Grants
are paid proportional to the degree of implementation of commitments specified in a contract between the
investor and the Minister of Economy.
Large part of the grants co-financed by the EU structural funds have already been used. One year prior
to the end of the 2007–2013 budget, over 80% of the available funds have been allocated. The remaining
funds are still available e.g. for investors implementing R&D projects. New round of structural funds will be
available in the next financial perspective 2014–2010.
Special Economic Zones
Special Economic Zones (SEZs) are separate areas designated for conduct of economic activities on
preferential terms. Businesses operating in SEZs may enjoy income and property tax exemptions in munici-
6 7
palities which have adopted a relevant resolution. They are also offered attractive investment plots with all
necessary infrastructure as well as assistance in legal and administrative procedures related to their project.
Various investment incentives are also available on the municipality level, as municipalities have the
power to offer exemptions for local taxes and charges, including property tax exemption.
Specific regulations relating to the sector
From May 2004, Polish pharmaceutical companies must comply with EU pharmaceutical regulations and
are only permitted to export their products to other EU in accordance with such regulations.
Drug registration process in Poland is regulated by the Pharmaceutical Law implementing Directive
2001/03/EC which aims to harmonise drug registration regulations across the EU markets. According to the
law, drug registration process in Poland should not take more than 210 days. In Poland, the administrative
authority competent for regulatory affairs is the Office for Registration of Medicinal Products, Medical De-
vices and Biocidal Products in Warsaw (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych
i Produktów Biobójczych) under the authority of the Minister of Health.
A new drug reimbursement law effective since January 2012 has brought about significant changes to the
Polish pharmaceutical market, with new provisions aiming to reduce drug reimbursement expenditures of
the National Health Fund (estimated to ca. 1.5 bn PLN annually26 which is equal to about 360 m EUR).
The main provisions of the Act:
• set a ceiling on reimbursement expenditure amounting to 17% of the total public healthcare expenditure.
Where this limit is exceeded, pharmaceutical companies shall be responsible to pay back 50% of the
overspend above the 17% limit;
• introduce fixed, official retail prices and margin for reimbursed medicines in pharmacies. Prices will be
negotiated by the Minister of Health with pharmaceutical companies;
• introduce a wholesale margin of 7%, 6% and 5% for 2012, 2013 and 2014 respectively;
• set an advertising ban on pharmacies and a ban on discounts relating to reimbursed drugs.
Testimonial
“This year the Servier Group celebrates our 20 year presence in Poland. With our successful operations has
come the opportunity to invest in education, R&D and since 1997, in our industrial manufacturing operations
at Anpharm S.A. in Warsaw. These operations have enabled us to serve the domestic and regional markets
with our innovative medication.
In Poland we are delighted to have a well-educated, highly qualified workforce with relevant industrial ex-
perience in the pharmaceutical and life science sectors. As an investor we have had positive experience in
executing capital investment projects. The availability of the required skillset in designers, contractors and
with good support from our local authorities has contributed enormously to our success in these projects.
Over the last 15 years we have continued to expand our operations as demonstrated in 2011 with an in-
vestment in a new line dedicated to cardiovascular products for the local and regional markets. This brings
to 135 M PLN the total invested in our manufacturing operations alone which employ up to 180 staff and
service providers. Overall, the Group has invested 620 M PLN in Poland since 1992 and currently employs
720 people in manufacturing, R&D and promotion”.
Colm Murphy, Production Site Director, Servier Group (Anpharm SA)
Trade exhibitions and events
Event Contact details Data
Fair of Medical Diagnostic TARGI KIELCE S.A. September
and Therapeutic Equipment Zakładowa1, 25-672 Kielce
and Appliances MEDYCYNA XXI Tel.: +48 41 365 12 22
http://www.targikielce.pl/
EUROBIOTECH Targi w Krakowie sp. z o.o. October
Centralna 41 A, 31-586 Kraków
Tel.: + 48 12 644 59 32
http://www.eurobiotech.krakow.pl
Bioforum is the biggest biotech and biobusiness annual event in Central and Eastern Europe held each
year on a different country. The 2011 edition is scheduled to take place in May in the city of Budapest. For
more information please visit: http://www.cebioforum.com .
26
  Ustawa refundacyjna przynosi oszczędności. Dla NFZ http://www.tvn24.pl/wiadomosci-z-kraju,3/ustawa-refundacyjna-
przynosi-oszczednosci-dla-nfz,260900.htm. [Drug Reimbursement Act Brings Savings. To the National Health Fund. http://www.
tvn24.pl/wiadomosci-z-kraju,3/ustawa-refundacyjna-przynosi-oszczednosci-dla-nfz,260900.htm.]
 Important institutions and contacts
TRADE ASSOCIATIONS AND CHAMBERS The BioTechMed Advanced Technology Centre
Politechnika Łódzka
Polish Chamber of Pharmaceutical Industry Stefanowskiego 1/15, 90-924 Łódź
and Medical Devices (POLFARMED) Tel.: +48 42 631 32 66
Łucka 2/4/6, 00-845 Warszawa www.biotechmed.pl
Tel.: +48 22 654 53 52
sekretariat@polfarmed.com.pl Ochota Biocentre Consortium
www.polfarmed.pl Instytut Medycyny Doświadczalnej i Klinicznej
im. M. Mossakowskiego PAN
Polish Union of Employers Pawińskiego 5, 02-106 Warszawa
in Pharmaceutical Industry Tel.: +48 22 668 52 50
Wiśniowa 40b/4, 02-520 Warszawa www.biocentrumochota.gov.pl
Tel.: +48 22 542 40 80
biuro@producencilekow.pl InnoBioBiz Cluster Łódź
www.pzppf.com.pl Biuro Analiz i Strategii Uniwersytetu Medycznego
w Łodzi
Employers’ Union of Innovative Pharmaceutical Kościuszki 4, 90-419 Łódź
Companies (INFARMA) mikolaj.gurdala@umed.lodz.pl
Puławska 17, 02-515 Warszawa
Tel.: +48 22 852 82 30 TECHNOLOGY PARKS
biuro@infarma.pl Technology Park at the Jagiellonian Centre
www.infarma.pl of Innovation
LifeScience Park
Polish Council for Supplements and Nutritional Bobrzyńskiego 1, 30-348 Kraków
Foods  Tel.: +48 12 297 46 00
Chłodna 64, 00-872 Warszawa www.jci.pl
Phone: + 48 22 620 29 34
info@krsio.org.pl The Wrocław Research Centre (WRC EIT+)
www.krsio.org.pl Stablowicka 147, 54-066 Wrocław
Tel.: +48 71 720 16 01
Polish Federation of Biotechnology biuro@eitplus.pl
Instytut Biochemii Technicznej Politechniki Łódzkiej
Stefanowskiego 4/10, 90-924 Łódź Wrocław Technology Park
Tel.: +48 42 631 34 29 54-424 Wrocław
www.pfb.p.lodz.pl Tel.: +48 71 798 58 00
www.technologpark.pl
Natural Heritage Association (Ecosystem)
Krakowskie Przedmieście 66, 00-950 Warszawa Poznań Science & Technology Park
Tel.: +48 22 828 70 02+48 22 828 80 11 Rubież 46, 61-612 Poznań
www.dziedzictwonatury.pl Tel.: +48 61 82 79 700
www.ppnt.poznan.pl
BioTechnolog.pl
Legionowa 2/49, 20-048 Lublin Nickel Technology Park Poznań (NTPP)
Tel.: +48 608 304 379 Krzemowa 1, Złotniki
http://www.biotechnolog.pl 62-002 Suchy Las
Tel.: +48 61 65 85 499
www.ntpp.pl
CLUSTERS AND CONSORTIUMS
Gdańsk Science & Technology Park
Nutribiomed Cluster Trzy Lipy 3, 80-172 Gdańsk
Wrocławski Park Technologiczny Tel.: +48 58 739 61 17
Klecińska 125, 54-413 Wrocław www.gpnt.pl
Tel.: +48 71 798 58 08
www.nutribiomed.pl Pomeranian Science and Technology Park
(PPNT)
LifeScience Cluster Kraków Zwycięstwa 96/98, 81-451 Gdynia
Bobrzyńskiego 14, 30-348 Kraków Tel.: +48 58 735 11 42
Tel.: +48 12 297 46 05 www.ppnt.pl
www.lifescience.pl
TechnoPark Łódź
Polish Technology Platform for Innovative Łódzki Regionalny Park Nauki i Technologii
Medicine (PPTIM) Sp. z o.o.
Wolska 88, 01-141 Warszawa Dubois 114/116, 93-465 Łódź
Tel.: +48 22 321 51 00 Tel.: +48 42 684 44 44
www.innowacyjnamedycyna.pl www.technopark.lodz.pl

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Financed by the Ministry of Economy